.Sponsor Dedicated Global Project Manager II - remote in one of the following countries - Belgium, UK, Denmark, Germany, Italy, Poland or Spain. Good to have Post-Trial Access (PTA) and Expanded Access Program (EAP) experience Syneos Health Healthcare Careers – Barcelona, BarcelonaSponsor Dedicated Project Manager II - Belgium, Denmark, Germany, Italy, Poland or Spain.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos HealthWe are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.Job responsibilitiesDevelop and maintain study project plan covering all study related activities/timeline tracking and review regularly with study team.Ensure timelines for design, build and release of production database are in alignment with First site activated.Define what reports from Database Programming are required for each study above and beyond the standard DM reports.Ensure Medical Monitor has access to lab portal and alerts; SAE, ECG or other alerts, as applicable.Develop process for Selection of Coordinating Investigator, if applicable.Develop/Implement process for Site activation, IP release, kit delivery, systems access etc at time of Regulatory Green light.Ensure processes are in place to Develop Country-Specific Informed Consent Form(s).Ensure Implement of escalation process for timely Creation, collection and approval Site Regulatory Packages in both internal and external models.Central IRB/EC Management.Oversight of Regulatory submission process timelines